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Adjuvanted RZV vaccine

Phase 2

Cardiovascular Disease | Vaccine | Cardiovascular |GSK plc|Last Updated: Jul 17, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment450

FDA Designations

No designations recorded

Clinical trial landscape

Adjuvanted RZV vaccine · 1 trial · 1 indication

Phase 2 1
NCT07712380A Study Exploring the Effect of Adjuvanted RZV or RSVPreF3 Vaccines on Coronary Plaque Progression in Adults >=50 Years of Age at Risk for Cardiovascular EventsCardiovascular Disease
NOT YET_RECRUITING450 Analytics
PHASE2NOT YET_RECRUITING
A Study Exploring the Effect of Adjuvanted RZV or RSVPreF3 Vaccines on Coronary Plaque Progression in Adults >=50 Years of Age at Risk for Cardiovascular Events
Cardiovascular DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in total coronary non-calcified plaque volume (NCPV) as measured on coronary computed tomography angiography (CCTA)
At Baseline (Day 1) and at Month 14

Secondary Endpoints

Change from Baseline in total coronary plaque volume as measured on CCTA
At Baseline (Day 1) and at Month 14
Change from Baseline in low attenuation plaque as measured on CCTA
At Baseline (Day 1) and at Month 14
Change from Baseline in peri-coronary fat attenuation index as measured on CCTA
At Baseline (Day 1) and at Month 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Placebo groupPLACEBO_COMPARATORParticipants in this group receive placebo, the first dose being administered at Day 1 and the second dose at Month 2.
Adjuvanted RZV groupEXPERIMENTALParticipants in this group receive the adjuvanted RZV vaccine, the first dose being administered at Day 1 and the second dose at Month 2.
Adjuvanted RSVPreF3 groupEXPERIMENTALParticipants in this group receive a single dose of placebo at Day 1 and a single dose of the adjuvanted RSVPreF3 vaccine at Month 2.

Interventions

NameTypeDescription
PlaceboCOMBINATION_PRODUCTPlacebo will be administered intramuscularly.
Adjuvanted RZV vaccineCOMBINATION_PRODUCTAdjuvanted RZV vaccine will be administered intramuscularly.
Adjuvanted RSVPreF3 vaccineBIOLOGICALAdjuvanted RSVPreF3 vaccine will be administered intramuscularly.
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Participants, including participants with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure....

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Recent Changes (Last 90 Days)

LOWJul 17, 2026NCT07712380NEW_TRIAL: changed
LOWJul 17, 2026NCT07712380NEW_TRIAL: changed

Frequently asked questions about Adjuvanted RZV vaccine

What is Adjuvanted RZV vaccine used for in cardiovascular disease?

Adjuvanted RZV vaccine is being studied for use in cardiovascular disease, specifically to explore its effect on coronary plaque progression in adults aged 50 years and older who are at risk for cardiovascular events. It is an investigational vaccine currently in Phase 2 clinical development.

What does Adjuvanted RZV vaccine target?

Adjuvanted RZV vaccine is a vaccine modality designed to elicit an immune response. The specific molecular target is not disclosed in the available information. The ongoing trial evaluates its effect on coronary plaque progression in adults at risk for cardiovascular events.

Who makes Adjuvanted RZV vaccine?

Adjuvanted RZV vaccine is being developed by GSK plc, a biopharma company listed on the stock exchange under the ticker GSK. The company is conducting a Phase 2 clinical trial to evaluate the vaccine's effect on cardiovascular disease.

What phase is Adjuvanted RZV vaccine in?

Adjuvanted RZV vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing Phase 2 trial is designed to explore its effect on coronary plaque progression in adults at risk for cardiovascular events.

What clinical trials is Adjuvanted RZV vaccine in?

Adjuvanted RZV vaccine is being evaluated in one Phase 2 clinical trial with the identifier NCT07712380. This randomized, double-blind, placebo-controlled study is investigating the effect of Adjuvanted RZV or RSVPreF3 vaccines on coronary plaque progression in adults aged 50 years and older at risk for cardiovascular events. The trial is not yet recruiting and plans to enroll 450 participants.